Prostatilen (Prostamax)
Also known as: Prostamax · Prostatilen AC (zinc arginyl-glycinate variant) · Vitaprost (clinical sister-formulation of the same prostate extract) · Prostate polypeptide complex / prostate cytomedine · Related designed short peptide: Vesugen (Lys-Glu-Asp, KED)
Research focus
Prostate gland — chronic prostatitis, benign prostatic hyperplasia (BPH), and associated male reproductive/urinary dysfunction
US regulatory status
Not FDA-approved · Not compoundable
Evidence rating
Emerging
Origin
Prostatilen is a water-soluble polypeptide complex extracted from the prostate glands of young cattle (bovine prostate), developed in the Soviet/Russian "cytomedine" tradition of tissue-derived bioregulators. It is one of the original organ extracts from the program led by Vladimir Khavinson and colleagues that later became the St. Petersburg Institute of Bioregulation and Gerontology — the same lineage that produced Thymalin (thymus), Cortexin (brain cortex) and Epithalamin (pineal). Unlike the later synthetic "Cytogen" short peptides, Prostatilen is an extract, so it is a mixture of low-molecular-weight peptides rather than one defined amino-acid sequence. According to PubMed, the first clinical reports appeared in 1991 from Soviet urology groups, with Khavinson listed as a co-author (Vozianov, Gorpinchenko, Boiko, Drannik, Khavinson [DOI unavailable — PMID 1823683]; Tkachuk, Gorbachev, Khavinson [PMID 1823682]). The compound is registered and marketed as a prescription urological drug (rectal suppositories and injectable forms) in Russia and several post-Soviet states under names including Prostatilen and the sister-brand Vitaprost; "Prostamax" is a marketed synonym in that region. A reformulated version, Prostatilen AC, adds a zinc arginyl-glycinate complex and has been studied separately. As part of the broader Khavinson short-peptide design program, a corresponding synthetic tripeptide for vascular/prostatic tissue, Vesugen (Lys-Glu-Asp), was later proposed, though its data are in-vitro only ([DOI](https://doi.org/10.1007/s10517-012-1664-1), Khavinson et al., 2012).
Plain-language summary
Prostatilen (also sold as Prostamax, and closely related to Vitaprost) is not a single molecule — it is a mixture of small peptides extracted from cattle prostate glands. It came out of the same Soviet/Russian "tissue bioregulator" program as Khavinson's other organ extracts, and in Russia and nearby countries it is a registered prescription drug for prostate conditions, given as a rectal suppository or injection. There is more human data behind it than behind most peptides in this category: small clinical trials in chronic prostatitis and benign prostate enlargement going back to 1991, plus a 2022 Phase III trial of a zinc-added version (Prostatilen AC) in men with sperm problems. The catch is that almost all of this research comes from a narrow group of Russian and Ukrainian urology centers, the studies are mostly small and open-label (patients and doctors knew who got the drug), and the strongest trial tested the zinc-enhanced formula rather than plain Prostatilen. It is not approved or legal for clinical use in the United States. None of this should be read as evidence that it cures or treats any condition.
Claimed mechanism (as reported)
Within the "cytomedine"/bioregulator framework, Prostatilen is proposed to act as a tissue-specific regulator of prostate cells rather than as a classic drug. Published Russian and Ukrainian work reports — without an established receptor-level mechanism — inflammation-reducing, anti-oedema, microcirculation-improving, and antioxidant effects on prostate tissue, plus claimed immunomodulating and platelet/anticoagulant activity. In rat hyperplasia models the extract reportedly normalized the prooxidant-antioxidant balance and prevented increases in prostate mass ([DOI](https://doi.org/10.1007/s10517-005-0287-1), Belostotskaya et al., Bull Exp Biol Med, 2005). At the cell-culture level, the Khavinson group proposes that short prostate-associated peptides such as Vesugen (Lys-Glu-Asp) tissue-specifically stimulate differentiation-factor expression (e.g., CXCL12) in prostatic fibroblasts ([DOI](https://doi.org/10.1007/s10517-012-1664-1), 2012). The molecular mechanism — including which peptide species in the extract are active and how they reach prostate cells after rectal or intramuscular administration — remains undefined and is supported mainly by in-vitro and animal work from a small set of affiliated groups. Mechanistic claims here are reported, not proven.
Evidence summary
Among Khavinson-lineage bioregulators, Prostatilen sits at the higher-evidence end because, unlike the purely synthetic Cytogens, it has a genuine (if methodologically weak) human clinical literature stretching from 1991 to a 2022 Phase III randomized controlled trial. According to PubMed, that body of work includes early open-label trials in hundreds of chronic-prostatitis patients, repeated clinical experience in BPH from St. Petersburg urology groups, and rat-model mechanistic studies — several indexed in Bulletin of Experimental Biology and Medicine and Russian/Ukrainian urology journals. The important caveats: the evidence is dominated by a small number of affiliated Russian and Ukrainian centers; most human studies are small, single-group, and unblinded; the one clearly randomized, multicenter, Phase III trial tested the zinc-enhanced derivative Prostatilen AC against plain Prostatilen (not against placebo) and measured semen parameters over only ~10 days; and there is no large, independently replicated, placebo-controlled English-language RCT of plain Prostatilen for a hard clinical endpoint as of 2026. The grade is "Emerging" rather than "Strong" on that basis, and nothing here establishes efficacy in the regulatory sense. A multi-source review added a 2022 phase III randomized multicenter trial of Prostatilen AC (with zinc) in chronic abacterial prostatitis with impaired sperm parameters (n=98), a 2020 randomized LLLT+Prostatilen infertility study (n=97), and a 2021 comparative vitaprost BPH study (n=60); an independent 2018 Cochrane review of chronic-prostatitis interventions is a skeptical external benchmark for the field. The Prostatilen-specific trials are open-label and manufacturer-adjacent. No trials are registered on ClinicalTrials.gov.
What the research reports
The use of prostatilen in treating patients with chronic prostatitis / with prostatic diseases (two 1991 reports)
Grade CTkachuk VN, Gorbachev AG, Khavinson VKh; and Vozianov AF, Gorpinchenko II, Boiko NI, Drannik GN, Khavinson VKh · Urologiia i Nefrologiia (Urol Nefrol Mosk) · 1991
Reported finding: Intramuscular Prostatilen (5–10 mg/day for 5–10 days) was reported to reduce pain and dysuria symptoms and improve uroflow and prostatic-secretion findings, with claimed antibacterial/immunomodulating effects and no recorded adverse reactions. These are uncontrolled, unblinded observations from the drug's developers.
Sample: n=307 chronic prostatitis (one report); n=37 prostatitis + n=15 adenoma (companion report)
Methodology: C — foundational open-label clinical trials, no placebo control, single-region groups, Khavinson a co-author
Limitations: No blinding, no placebo arm, outcomes partly subjective, conflict of interest (developing group), Russian-language only.
Influence of adding zinc arginyl-glycinate to bioregulatory peptides of the prostate gland in patients with impaired sperm parameters (Prostatilen AC, Phase III RCT)
Grade CRybalov M, Borovets S, Petlenko S, Krasnov A, Apryatina V · Georgian Medical News · 2022
Reported finding: Over ~10 days, the zinc-enhanced Prostatilen AC suppositories reportedly improved sperm motility and morphology more than plain Prostatilen suppositories. This compares two active formulations, so it does not establish efficacy of Prostatilen itself versus placebo.
Sample: n=98 men (25–45 y) with chronic abacterial prostatitis and reproductive dysfunction
Methodology: C+ — randomized, multicenter, Phase III; but open-label and an active-comparator (not placebo) design on a short timeframe
Limitations: Open-label, active-comparator (no placebo), very short follow-up, surrogate semen endpoints, single-region investigators, tests the derivative AC formula.
Prostatilen in benign prostatic hyperplasia: voiding disorders and prostatic-adenoma clinical experience
Grade CAl'-Shukri SKh, Gorbachev AG, Borovets SIu, Kuz'min IV et al. · Urologiia (Moscow) · 2003–2006
Reported finding: Rectal suppositories containing prostatilen (with dimexide) were reported to relieve infravesical-obstruction symptoms and reduce residual urine in early/moderate BPH, presented as an adjunct or low-cost option. Observational, without randomization.
Sample: n=96 BPH patients (51–89 y) in one report; ~1115-patient urology case series in another
Methodology: C — clinic case series / small clinical reports, mostly uncontrolled
Limitations: Largely uncontrolled clinical experience, heterogeneous protocols, single-institution, Russian-language, no long-term hard endpoints.
Prooxidant-antioxidant balance and anti-hyperplasia effects of Prostatilen in rat prostatic-hyperplasia models
Grade DBelostotskaya LI, Gomon ON, Nikitchenko YuV, Chaika LA et al.; Savateeva-Liubimova TN, Sivak KV, Malinin VV (AC suppositories) · Bulletin of Experimental Biology and Medicine; Eksperimental'naia i Klinicheskaia Farmakologiia; Urologiia · 2005–2012
Reported finding: In sulpiride- or hyperprolactinemia-induced rat prostatic hyperplasia, Prostatilen reportedly prevented increases in prostate mass and normalized lipid-peroxidation/antioxidant markers; the AC variant reportedly showed antioxidant and inflammation-modulating effects in an experimental prostatitis model. Mechanism-suggestive, not clinical.
Sample: Rodent cohorts (e.g., n≈40 rats for the AC suppository prostatitis model)
Methodology: D/C — preclinical animal and in-vitro mechanistic studies
Limitations: Animal/in-vitro only, small samples, single research lineage, does not establish human efficacy or define the active peptide(s).
Prostatilen AC (with zinc) versus Prostatilen in men with impaired sperm parameters — phase III randomized multicenter trial
Grade CRybalov M, Borovets S, Petlenko S et al. · Georgian Medical News (PubMed-indexed) · 2022
Reported finding: Prostatilen AC (with added zinc arginyl-glycinate) was reported to improve sperm motility and morphology significantly more than Prostatilen alone over 10 days.
Sample: n=98 men (49 Prostatilen AC vs 49 Prostatilen), chronic abacterial prostatitis with reproductive dysfunction
Methodology: C — phase III, randomized, multicenter, but open-label active-comparator (no placebo), 10-day therapy, surrogate semen endpoints
Limitations: Active-comparator without placebo; very short duration; surrogate semen parameters; manufacturer-adjacent.
Bioregulatory peptides (vitaprost) in men with benign prostatic hyperplasia and chronic prostatitis
Grade DKuzmenko AV, Vinnik YuYu, Kuzmenko VV et al. · Urologiia (Moscow) · 2021
Reported finding: Adding vitaprost tablets to alpha-blocker/fluoroquinolone therapy was reported to reduce lower-urinary-tract symptom scores (IPSS, NIH-CPSI) and prostatic inflammation markers faster than standard therapy alone.
Sample: n=60 (30 standard therapy vs 30 standard + vitaprost)
Methodology: D — small two-group open-label comparative (allocation not randomized as described)
Limitations: Small, open-label, short follow-up; combination design; surrogate symptom endpoints.
Administration reported in studies
In the published Russian/Ukrainian literature, Prostatilen has been studied chiefly as a registered prescription drug given in short courses: intramuscular injection of roughly 5–10 mg once daily for about 5–10 days in the early chronic-prostatitis trials, and as rectal suppositories (commonly cited around 30 mg prostatilen, sometimes combined with dimexide/DMSO, or 3 mg in the Prostatilen AC formulation) given once daily for courses of roughly 10–15 days, occasionally repeated every few months in BPH. The zinc-enhanced Prostatilen AC Phase III trial used once-daily suppositories for about 10 days. This is a summary of research conditions — not a dosing recommendation and not a protocol endorsed by TPC.
This section reports what published studies describe. It is not a dosing recommendation from TPS.
Safety record
As a registered urological drug in its region of origin, Prostatilen has been used in thousands of patients, and the source publications repeatedly report good tolerability with "no adverse reactions" or no observed adverse effects over short treatment courses. That reassurance must be read critically: these statements come from mostly open-label, short-duration studies run by affiliated groups, with no rigorous adverse-event capture, no long-term safety follow-up, and no independent pharmacovigilance in the English-language literature. As a bovine tissue-derived biological, it also carries the theoretical considerations that apply to any animal-extract product (immunogenicity, batch-to-batch variability, and source-material/contamination control). Material sold online as "research chemical" prostate peptide is not the registered pharmaceutical, is not quality-controlled, and is not verified by TPC. No claim of being safe, fully safe, or side-effect-free is supported.
US legal status
Not FDA-approved for any indication. Not on the FDA 503A compoundable bulk drug substances list, and not legally compoundable for human clinical use in the United States. Its registration as a urological medicine in Russia and some post-Soviet countries has no bearing on US legality. Where sold online (including to US buyers) it is offered only as a "research chemical" — that channel is unregulated, product identity and purity are unverified, and such vendors are not verified or endorsed by TPC.
Open research questions
- ? Is plain Prostatilen better than placebo for a hard clinical endpoint (e.g., validated prostatitis symptom scores, IPSS, uroflow) in a large, double-blind, independently run RCT — rather than the largely open-label, single-region studies and active-comparator AC trial that dominate the current record?
- ? Can any of the reported benefits be replicated by groups with no connection to the developers or manufacturer, in English-language peer-reviewed journals?
- ? What are the actual active peptide species in the extract, and what is the pharmacokinetic/pharmacodynamic basis for activity after rectal or intramuscular dosing — including how (or whether) relevant peptides reach prostate tissue intact?
- ? What is the long-term safety profile (beyond 10–15-day courses), including immunogenicity and source-material quality control for a bovine-derived biological, and how does the synthetic tripeptide Vesugen (Lys-Glu-Asp) compare, given its data are in-vitro only?
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